Precision BioSciences has received clinical trial application (CTA) approval to expand its global ELIMINATE-B study of PBGENE-HBV, an in vivo gene editing therapy for chronic hepatitis B.
The regulatory clearance authorises the start of key clinical trial sites in France and Romania, enhancing the trial’s European presence alongside existing locations in Hong Kong, Moldova, New Zealand, the UK, and the US.
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The inclusion of new clinical trial locations is expected to support patient enrolment and clinical trial execution for ELIMINATE-B, aiming to treat a greater number of patients with PBGENE-HBV.
Precision has commenced site initiation activities and anticipates the first patient screening to begin in the second quarter (Q2) of 2026.
Chronic hepatitis B is a serious condition that leads to liver inflammation, persistent infection, and a heightened risk of liver cancer or cirrhosis.
PBGENE-HBV is designed to eliminate covalently closed circular deoxyribonucleic acid (cccDNA) and inactivate integrated hepatitis B virus (HBV) DNA, directly targeting the underlying cause of chronic hepatitis B.
The ELIMINATE-B trial explores PBGENE-HBV across multiple dosing levels to assess its potential as a curative treatment.
The programme has received fast track designation from the US Food and Drug Administration (FDA), with regulatory guidance supporting sustained loss of HBV DNA as an approvable endpoint.
Precision BioSciences chief development and business officer Cindy Atwell said: “Expanding ELIMINATE-B into hepatitis sites in France and Romania is an important step in the continued development of PBGENE-HBV, the only gene editing therapy uniquely designed to eliminate cccDNA.
“Given the strong investigator interest in PBGENE-HBV, especially following the late breaker oral presentation at The Liver Conference 2025, these new trial sites will build on our existing global clinical trial footprint as we advance PBGENE-HBV through the ELIMINATE-B trial.”
In February, Precision received a Study May Proceed notification from the FDA, permitting initiation of institutional review board (IRB) activities and site activation for its Phase I/II FUNCTION-DMD trial of PBGENE-DMD in ambulatory Duchenne muscular dystrophy (DMD) patients.
